510(k) · Cleared
ClearedEmoLED (v. 2-USA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emoled, Srl · GEX Powered Laser Surgical Instrument
Cleared on Mar 12, 2024 as substantially equivalent to K200659 (Aesthetic Technology, Ltd., 2020) and 1 other predicate after a 55-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Mar 12, 2024
- Review
- 55 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943450 (1995). 109 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- 2 generations backK172555 Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 2018
- 1 generation backK232656 BLU TOTALE (Model: ENEOB852)Premier North America, Inc. · 2023
- This deviceK240132 EmoLED (v. 2-USA)Emoled, Srl · 2024
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 8 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 7 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 6 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 5 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 4 generations backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- 3 generations backK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- 2 generations backK172555 Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 2018
- 1 generation backK232656 BLU TOTALE (Model: ENEOB852)Premier North America, Inc. · 2023
- This deviceK240132 EmoLED (v. 2-USA)Emoled, Srl · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −8 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −7 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −6 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −5 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −4 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| −3 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| −2 | K172555 | Sapphire, Elevare Sapphire | Omm Imports, Inc. D/B/A Zero Gravity | 2018 | — |
| −1 | K232656 | BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. | 2023 | — |
| 0 (this device) | K240132 | EmoLED (v. 2-USA) | Emoled, Srl | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 11 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200659 | Dermalux Tri-Wave MDSummary page 5…ly Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200659 Dermalux Tri-Wave MD GEX K232656… | 2020 |
| * | K232656 | BLU TOTALE (Model: ENEOB852)Summary page 5…Product Code K200659 Dermalux Tri-Wave MD GEX K232656 BLU TOTALE OLP Device De… | 2023 |
| † | K190938 | Phototherapy System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 109 ancestors have a recall of any class.
- 2 other devices also cite its predicate K200659.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The EmoLED device is intended to provide photo therapeutic light to the body. The EmoLED device is generally indicated to treat dermatological conditions. The EmoLED device is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240132: EmoLED (v. 2-USA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240132
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026